Teleflex Says It Will Lose $9m – And Maybe More – Due To EtO Plant Shutdown
The medical device-maker says it will lose millions by the end of the fiscal year because Georgia regulators have temporarily shut down Sterigenics’ ethylene oxide sterilization (EtO) facility near Atlanta. With no news on when it will reopen, the company says it may lose even more money next year.
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Urology device developer NeoTract, which Teleflex purchased in 2017, is now under scrutiny for potential FCA violations.
As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.
While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.